Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 074615
Company: CHARTWELL RX
Company: CHARTWELL RX
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| GEMFIBROZIL | GEMFIBROZIL | 600MG | TABLET;ORAL | Discontinued | None | No | No |
Original Approvals or Tentative Approvals
| Action Date | Submission | Action Type | Submission Classification | Review Priority; Orphan Status | Letters, Reviews, Labels, Patient Package Insert | Notes | Url |
|---|---|---|---|---|---|---|---|
| 09/29/1995 | ORIG-1 | Approval |
Label is not available on this site. |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 04/08/2009 | SUPPL-7 | Labeling |
Label is not available on this site. |
||
| 12/12/1997 | SUPPL-4 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 01/25/1996 | SUPPL-3 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 02/22/1996 | SUPPL-2 | Labeling |
Label is not available on this site. |
||
| 02/22/1996 | SUPPL-1 | Manufacturing (CMC) |
Label is not available on this site. |